| CTRI Number |
CTRI/2018/04/013132 [Registered on: 10/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
01/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Comparative Pilot study on Medicated fumigation Wick with and without internal medicine of Gowri chinthamani chendhuram in the treatment of Sinusitis |
|
Scientific Title of Study
|
A Comparative Pilot study on Peenisa thiri (Medicated fumigation Wick) with and without internal medicine of Gowri chinthamani chendhuram in the treatment of Kaba peenisam(Sinusitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMSuganthi |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram Sanatorium
Chennai
department of maruthuvam
OPD no 1
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8056786753 |
| Fax |
|
| Email |
drsuganthi6@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrHVetha merlin kumari |
| Designation |
Lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram Sanatorium
Chennai
Department of maruthuvam
OPD No 1
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9894782366 |
| Fax |
|
| Email |
dr.vetha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMSuganthi |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram Sanatorium
Chennai
Department of maruthuvam
OPD No 1
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8056786753 |
| Fax |
|
| Email |
drsuganthi6@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital
National institute of Siddha
Tambaram Sanatorium
Chennai 47
Kanchipuram Dt
Department of Maruthuvam
OPD No 1 |
|
|
Primary Sponsor
|
| Name |
AYOTHIDOSS PANDITHAR HOSPITAL |
| Address |
National Institute of Siddha
Tambaram Sanatorium
Chennai 47
Department of maruthuvam
OPD No 1
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DRMSUGANTHI |
Ayothidoss Pandithar Hospital |
National Institute of Siddha
Department of Maruthuvam
OPD No 1 and IPD
Tambaram Sanatorium
Chennai 47
Kancheepuram
TAMIL NADU |
8056786753
drsuganthi6@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
KABHA PEENISAM (SINUSITIS), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gowri Chinthamani Chenthooram (Internal) and Peenisa Thiri (External |
200 mg of Gowri chinthamani chenthooram administered orally twice a day with 500 mg tablets of Thirikadugu chooranam for a period of 24 days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients who having the symptoms of pain in the face , purulent nasal discharge , head ache or heaviness of head , sneezing , fever , tooth ache , nasal block and presence of any three symptoms.
2) Patient willing to sign the informed consent stating that he / she will conscientiously stick to the treatment during 24 days but can opt out of the trial of his / her own conscious discretion
3) Patients who are willing for radiological investigations (Xray for Paranasal sinuses) and provide blood , urine for lab investigations. |
|
| ExclusionCriteria |
| Details |
1)H/O Bronchial asthma
2)H/O Tuberculosis
3)H/O Diabetes mellitus
4)H/O Hypertension
5)H/O Heart disease
6)H/O Chronic obstructive pulmonary disease
7)H/O Thyroidism
8)H/O Renal disease |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the therapeutic efficacy of "Peenisa thiri" (Medicated fumigation wick) with and without "Gowri chinthamani chenthooram" (Internal) for the changes in the lab parameters in "Kabha peenisam" (Sinusitis) |
To compare the therapeutic efficacy of "Peenisa thiri" (Medicated fumigation wick) with and without "Gowri chinthamani chenthooram" (Internal) for the changes in the lab parameters in "Kabha peenisam" (Sinusitis) for a period of 24 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study the reduction in clinical symptoms and changes in lesion in radiological investigation
2)To study the siddha principles such as 3 humours, Naadi, 8 diagnostic method, Neerkuri, Nei kuri, 7 body constituents etc..
3)To study the prevalence of disease with age, sex, occupation , socio economic status etc..
|
pre study screening and after treatment |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/01/2016 |
| Date of Study Completion (India) |
23/03/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a single non randomized open lable trial to determine the efficacy and safety of peenisa thiri (external medicine) with and without gowri chinthamani chenthooram (internal medicine )in patients with kabha peenisam (sinusitis).in this trial 20 patients will be recruited. the trial drug gowri chinthamani chenthooram 200mg twice a dayand peenisa thiri will be administered for 10 patients and the external medicine peenisa thiri will be administered for 10 patients for a period of 24 days.during the trial period if any AE/SAE/SUSAR will be noticed and refered to pharmacovigilance dept of NIS and further management will also be given in NIS OPD/IPD. The entire trial will be monitor by the research monitoring commitee of NIS.During this trial all the safety and efficacy parameter will be recorded in CRF.After completion of the trial all this study related data will be analysed statistically.The outcome of this trial will be puplished in indian journal of medical research. |